MODEL SB100II FINGER PULSE OXIMETER

{0}------------------------------------------------ | | Page 1 of 6<br>02-Jun-2010 | | |----------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------| | Official Contact: | CY Wang - RD VP<br>Atlantean<br>1F, No. 789, Bo-ai Street<br>Chubay City, TAIWAN<br>Tel - 886-3-555-8340<br>Fax - 886-2-2736-3250 | K10156<br>SEP 20 2010 | | Proprietary or Trade Name: | SB100II Finger Pulse Oximeter | | | Common/Usual Name: | Pulse oximeter | | | Classification Name: | Oximeter<br>DQA - 870.2700 | | | Predicate Devices: | Contec Medical Systems, K082641, CMS-50DL<br>Smith's Medical, K013171, BCI3420 | | 510(k) Summary ### Device Description: The SB10011 pulse oximeter is an instrument for photoelectrically determining the oxygenation of blood in a translucent part of the body, in this case the finger. This SB1001 contains the electronics to interface to the integral sensor. This sensor consists of a light emitting diode and a photoelectric cell placed on either side of the finger. Red and infrared light are transmitted through oxyhemoglobin and are sensed in the photoelectric cell. The red and infrared light is absorbed in different amounts depending on the oxygenation of the blood. The SB10011 has the ability to determine both the percent of saturated hemoglobin and the pulse rate. It performs these functions on adult and pediatric patient populations. It is designed for spot checking both the SpO2 and Pulse rate information. To perform this, the SB100Il display digital values for both the SpO2 and Pulse. Pulse amplitude is displayed graphically by means of a vertical bar, which elevates in synch with the pulse cycle. The SB1001 is powered by two "AAA" batteries. The wavelength of red LED is 660nm and Infrared LED is 905/880nm with maximum optical output power of 4mW. The device incorporates a battery state indicator and provides a visual indication of low battery. ## Summary Description: - The SB10011 is not life-supporting or life-sustaining, not for implant. . - The SB100II is not sterile . - ◆ The SB100H is reusable. - The SB10011 is for prescription use. . - The SB100II does not contain drug or biological products ● - The SB100H is a class II device, product code DQA regulation 21 CFR 870.2700. . {1}------------------------------------------------ # 510(k) Summarv Page 2 of 6 02-Jun-2010 - The SB100II is a standalone device it is not part of a multi-parameter module and does . not connect to any other devices - The SB100H is for use in spot-checking it is not intended for continuous monitoring. . - The SB10011 is not intended for out of hospital transport . - . The SB100II can be used in homes. - The SB10011 is a transmittance device that calculates functional SpO2 . - . The SB100II does not provide audio or visual alarms - The SB100I1 has only one control the On / Off key. When the device is on it can . display the following: - ୍ତ SpO2 values - Pulse Rate o - An indication of pulse amplitude. O - . There are no accessories for use with the SB1001. The sensor is integral to the device and is spring loaded so that it does not need to be adhered to the skin by tape or other measures. - The SB100H is a standalone device that does not interface to any other devices so there . are no patient cables, extender cables, sensors or external power supplies. - . The SB100II is not provided sterile is not intended to be sterilized. - . The SB100II is not a reprocessed device. - . The SB10011 does not have multiple modes. It is on or off, when it is on, it measures SpO2 and pulse rate as described above. - . There are no claims relative to motion tolerance - . There are no claims relative to low perfusion ### Indications for Use: The SB10011 Fingertip Pulse Oximeter is a non-invasive device intended for the spot-checking of oxygen saturation of arterial hemoglobin (SpO-) and the pulse rate of adult and pediatric patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care etc.). The SB10011 is not intended for continuous monitoring. ### Patient Population: Adult and pediatric patient populations Environment of Use: Home and hospital Contraindications: None {2}------------------------------------------------ Premarket Notification 510(k) Section 5 -- 510(k) Summary # 510(k) Summary . | Attribute | Smiths Medical<br>BC13420<br>510(k) K013171 | Contee Medical Systems<br>CMS50 DL<br>510(k) K082641 | Atlantean SB10011<br>(This submission) | Discussion of<br>Differences | |-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------| | Indications for Use | The BCI 3420 Digit Pulse Oximeter is<br>a handheld, finger mounted pulse<br>oximeter that combines the monitor<br>and sensor into one assembly that<br>measures SpO2, pulse rate and pulse<br>strength. It may be used as a spot<br>check device in the home, hospital or<br>clinical environments, including<br>patient ground transport in clinical and<br>EMS (Emergency Medical Services)<br>settings. The BCI 3420 Digit Pulse<br>Oximeter will provide reliable<br>measurements on patient ranging from<br>pediatric to adults. | The Fingertip Pulse Oximeter is<br>a non-invasive device intended<br>for the spot-check of oxygen<br>saturation of arterial hemoglobin<br>(SpO2) and the pulse rate of<br>adult and pediatric patients in<br>home and hospital environments<br>(including clinical use in<br>internist/surgery, anesthesia,<br>intensive care etc.). This device<br>is not intended for continuous<br>monitoring. | The SB10011 Fingertip Pulse Oximeter is<br>a non-invasive device intended for the<br>spot-checking of oxygen saturation of<br>arterial hemoglobin (SpO2) and the pulse<br>rate of adult and pediatric patients in<br>home and hospital environments<br>(including clinical use in internist /<br>surgery, anesthesia, intensive care etc.).<br>The SB10011 is not intended for<br>continuous monitoring. | Same as K082641 | | Environments of use | home, hospital or clinical<br>environments, including patient<br>ground transport in clinical and EMS<br>(Emergency Medical Services)<br>settings | home and hospital environments<br>(including clinical use in<br>internist/surgery, anesthesia,<br>intensive care etc. | home and hospital environments<br>(including clinical use in<br>internist/surgery, anesthesia, intensive<br>care etc. | Same as K082641 | | Intended application<br>site | Finger | Finger | Finger | Same | | Low perfusion claims | No | No | No | Same | | Motion Claims | No | No | No | Same | | Prescriptive | Yes | Yes | Yes | Same as K082641 | | Patient population | Pediatric / adult | Pediatric / adult | Pediatric / adult | Same | | Reusable | Yes | Yes | Yes | Same | | Display Type | LED | LED | LED | Same | | Attribute | Smiths Medical<br>BC13420<br>510(k) K013171 | Contec Medical Systems<br>CMS50 DL<br>510(k) K082641 | Atlantean SB10011<br>(This submission) | Discussion of<br>Differences | | Display Parameter | SpO2, Pulse Rate, Pulse Strength | SpO2, Pulse Rate, Pulse Strength | SpO2, Pulse Rate, Pulse Strength | Same | | Controls | On | On | On / off | Same | | Alarms | Unknown | Unknown | None | No alarms on SB10011 | | SpO2<br>Range | 0-99% | 35-99% | 35-99% | Same as K082641 | | Resolution | 1% | 1% | 1% | Same | | Accuracy | +/-2% 70-99% | +/-2% 70-99% | +/-3% 70-99% | Similar, actual Arms 2.5<br>Meets FDA guidance for<br>non-motion ≤ 3.0 %<br>Meets ISO 9919 for non-<br>motion <4.0 % | | Type | <70% unspecified | <70% unspecified | 35-69% unspecified | Same as K082641 | | Pulse<br>Range | 30-254 bpm | 30-250 bpm | 30-250 bpm | Same | | Accuracy | ±2% or 2 bpm whichever is greater | ±2% or 2 bpm whichever is<br>greater | ±3 bpm | Similar | | Resolution | 1 bpm | 1 bpm | 1 bpm | Same | | Power | 2 "AAA" batteries | 2 "AAA" batteries | 2 "AAA" batteries | Same | | Battery Life | 16 hours continuous<br>1400 spot checks | 30 hours | 16 hours continuous | Same time duration as<br>K013171 | | Attribute | Smiths Medical<br>BC13420<br>510(k) K013171 | Contec Medical Systems<br>CMS50 DL<br>510(k) K082641 | Atlantean SB10011<br>(This submission) | Discussion of Difference | | Environmental | | | | | | Dimensions | 57.2 x 43.3 x 38.1 mm | unknown | 63.5x34x35mm | Similar to K013171 | | Weight | 85g | Unknown | 37g | Lighter than K013171 | | Operating<br>Temperature | 10°C-55°C | Unknown | 5°C to 40°C | Similar to K013171 | | Storage Temperature | -40°C-75°C | Unknown | -20°C to 70°C | Similar toKk013171 | | Operating Humidity | 15%-95% | Unknown | 15%-95% | Similar to K013171 | | Storage Humidity | 10-95% | unknown | 15%-95% | Similar to K013171 | | Standards | | | | | | IEC 60601-1 | Yes (undated) | Yes (undated) | Yes IEC 60601-1: 1988 +A1+A2 | SB10011 meets current revision<br>of the recognized consensus<br>standard | | IEC 60601-1-2 | Yes EN 60601-1-2: 1993 | Yes (undated) | IEC 60601-1-2: 2001 +AI | SB100II meets current<br>recognized consensus standard | | ISO 9919 | Unknown | ISO 9919: 2005 | ISO 9919: 2005 | Same as k082641 (current<br>revision of the recognized<br>consensus standard) | | General | | | | | | Protection against<br>ingress of water | Unknown | Unknown | IPX1 and ISO 9919 Clause 44 | Meets FDA guidance | | Protection Class<br>(electrical safety) | Unknown | Unknown | Type BF | Protection class is suitable for | Page 5.20 {3}------------------------------------------------ Premarket Notification 510(k) Summary # 510(k) Summary Page 5.21 . {4}------------------------------------------------ Premarket Notification 510(k) Section 5 = 510(k) Summary # 510(k) Summary Page 5.22 {5}------------------------------------------------ # 510(k) Summary Page 6 of 6 . 02-Jun-2010 #### Performance Testing: The following performance tests were done and the SB100II meet all requirements. - . ISO 9919 including clinical testing - 1EC 60601-1-2 . - . IEC 60601-1 # Substantial Equivalence: The SB100II Pulse Oximeter is viewed as substantially equivalent to the predicate devices because it performs the same basic functionality by similar technical means. #### Indications - The SB10011 Fingertip Pulse Oximeter is a non-invasive device intended for the spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult and pediatric patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care etc.). The SB10011 is not intended for continuous monitoring. # Technology - The SB100H pulse oximeter is an instrument for photoelectrically determining the oxygenation of blood in a translucent part of the body, in this case the finger. This SB100II contains the electronics to interface to the integral sensor. This sensor consists of a light emitting diode and a photoelectric cell placed on cither side of the finger. Red and infrared light are transmitted through oxyhemoglobin and are sensed in the photoelectric cell. The red and infrared light is absorbed in different amounts depending on the oxygenation of the blood. # Materials - - -- The materials in contact with the patient as common to medical devices. ## Environment of Use - Home and hospital environments (including clinical use in internist/surgerv, anesthesia, intensive care etc.). Patient Population -Adult and pediatric {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. To the left of the bird symbol is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Atlantean C/O Mr. Paul E. Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134 SEP 2 0 2010 Re: K101568 Trade/Device Name: SB100II Finger Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: September 15, 2010 Received: September 16, 2010 Dear Mr. Dryden: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {7}------------------------------------------------ Page 2- Mr. Dryden Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. Jame O. Eastland Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ Indications for Use Statement K101568 SEP 2 0 2010 Page 1 of 1 510(k) Number: (To be assigned) Device Name: SB100II Finger Pulse Oximeter Indications for Use: The SB100II Fingertip Pulse Oximeter is a non-invasive device intended for the spotchecking of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult and pediatric patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care etc.). The SB100II is not intended for continuous monitoring. Prescription Use XX (Part 21 CFR 801 Subpart D) or Over-the-counter use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) L. Schuta Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices 510(k) Number: K101568